Debritom - Micro Water Jet Technology and Wound Healing

NCT ID: NCT04240574

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2021-08-06

Brief Summary

This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

Detailed Description

This is a prospective cohort, single-center, open-label study in subjects with chronic lower extremity wounds. The study will enroll up to 20 subjects. Subjects will undergo screening evaluations to determine eligibility to enroll in the study. All study subjects will receive micro water jet technology debridement as opposed to other debridement methods as part of their wound care treatment. The other aspects of subjects wound care protocol will remain unchanged. In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive micro water jet debridement on one or all of the ulcers.

Conditions

Diabetic Foot Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin; Venous Leg Ulcer; Venous Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micro Water Jet Technology (Debritom)

Debritom is a hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.

All subject will get the Debritom.

Group Type: OTHER

Debritom

Intervention Type: DEVICE

hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.

Interventions

Debritom

hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female age 18 or older
• The ability and willingness to provide Informed consent
• Presence of a chronic lower extremity ulcer
• Chronic ulcer is defined as that greater than 4 weeks in duration.
• Subject's informed consent for participation prior to proceeding with micro water jet technology debridement
• Patient's ulcer cannot exhibit any gross clinical signs of infection.
• Patient is willing to participate in all procedures and follow up evaluations necessary to complete the study.
• Patient willing and able to comply with having micro water jet technology debridement potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks.

Exclusion Criteria

• Patients with active wound infection, or untreated osteomyelitis
• Patients with dementia, or impaired cognitive function
• Patients who are unable or unwilling to participate in all procedures and follow up evaluations
• Patient has Active Charcot foot
• Patient with malignant wounds

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephanie Wu

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Wu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rosalind Franklin University Health Clinics

North Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MDX-DEB-001

Identifier Type: -

Identifier Source: org_study_id